UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of intraoperative use of remifentanil to postpoerative nausea and vomiting(PONV)
Title of the study (Brief title)	Influence of intraoperative use of remifentanilto PONV
Region	Japan

Condition
Condition	upper extremity surgery
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the influence of intraoperative use of remifentanil to PONV
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of postoperative nausea
Key secondary outcomes	Respiratory rate at the time of leaving Time until spontaneous breathing appear Total dose of remifentanil End-tidal sevoflurane concentration at the time of awakening NRS at rest

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The intraoperative use of remifentanil
Interventions/Control_2	The intraoperative nonuse of remifentanil
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ASA-PS 1-3 Patients who consent
Key exclusion criteria	Patients who did not consent Patients with allergy of local anesthetics Pregnant or lactating women Patients with liver failure or renal failure Patients with bradycardia(HR<40bpm)
Target sample size	150

Research contact person
Name of lead principal investigator	Tatsunori Watanabe
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Anestesio;ogy
Address	Asahimachi 1-757, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2328
Email	deepimpact034@yahoo.co.jp

Public contact
Name of contact person	Tatsunori Wataanbe
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Anestesio;ogy
Address	Asahimachi 1-757, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2328
Homepage URL
Email	deepimpact034@yahoo.co.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 11 Day
Anticipated trial start date	2015 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 05 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018694